Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of accelerated transcranial magnetic stimulation with h1-coil (dtms)

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to examine the efficacy and safety of accelerated transcranial magnetic stimulation with h1-coil (deep tms) for treatment of patients diagnosed with major depressive disorder (mdd). subjects will be randomized into two groups: experimental (treated with accelerated deep tms: twice a day (6-8 hours between two applications), during 2 weeks) and control group (standard deep tms treatment: once a day, during 4 weeks). participants and designated clinicians will complete a battery of instruments that measure relevant symptoms (ham-d17 and bdi-ii scales), global functioning (cgi and phq-9 scales), quality of life (eq-5d-5l questionnaire), and cognitive functions (moca test). measurements will be done in 4 time points: after the inclusion, after the first week of treatment, after the second week (the end of treatment for experimental group), after the fourth week (the end of treatment for control group), and after 1 month (follow-up for both groups). interim data analysis is planned at the time when at least 30 participants are involved in both groups. patients whose baseline score on ham-d17 is equal or greater than 24 (very severe depression) will be included in another study; they will be treated with accelerated deep tms twice a day during 4 weeks.


Eligibility criteria:
inclusion criteria: * diagnosed major depressive disorder (icd10: f32.1, f32.2, f33.1, f33.2) * current depressive episode lasts for at least 4 weeks * ham-d17 score ≥15 * cgi-score ≥4 * inadequate response to antidepressant therapy exclusion criteria: * diagnosed psychotic disorder * diagnosed depressive disorder with psychotic features * diagnosed bipolar affective disorder * diagnosed posttraumatic stress disorder * diagnosed obsessive-compulsive disorder * anxiety disorder or personality disorder as primary diagnoses * alcohol or drug addiction * neurological disorders and brain implants * pregnancy * former tms treatment within 6 months * unable to complete the questionnaires
a study for patients with type 1 diabetes mellitus

Conditions: Diabetes Mellitus, Type 1

Summary: the purpose of the study is to compare the human insulin inhalation powder plus insulin glargine with injected insulin (regular human insulin or insulin lispro) plus insulin glargine on lowering the blood sugar level.


Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus for at least 24 months * injecting insulin (insulin lispro, aspart or regular insulin, insulin lispro/aspart mixtures, or regular human insulin mixtures) in the last 24 months * hba1c equal or less than 11 % * nonsmokers, had not smoked for at least 6 months and agree not to smoke (cigars, cigarettes or pipes) or use smokeless tobacco for the duration of the study * satisfactory lung function results to meet the requirement of the study exclusion criteria: * previously received any form of inhaled insulin * require a daily total insulin dosage greater than 100 u * have a current or past history of asthma, chronic obstructive pulmonary disease or other clinically relevant lung disease * history or presence of liver disease * history or presence of kidney disease
giomer vs glass ionomer cement for art occlusoproximal restorations: a randomized clinical trial

Conditions: Dental Caries

Summary: although the atraumatic restorative treatment (art) is well settled in the literature regarding occlusal-proximal cavities, the longevity of these restorations is still lower when compared to occlusal ones. this factor is often associated with low mechanical properties of glass ionomer cements (gic). the objective of this randomized clinical trial is to evaluate the long-term cost-effectiveness of two different materials: an encapsulated gic - equia (gc corp), compared with giomer (beautifill bulk restorative - shofu) used as restoratives materials in occlusal-proximal art restorations of primary molars. children aged between 4 and 8 years, will be selected in schools in the city of cerquilho, são paulo. all restorations will be held following the precepts of the art and the manufacturer's instructions. the restorations will be evaluated after 3, 6, 12, 18 and 24 months according to roeleveld et al. (2006) criteria. to verify the survival of the restorations will be used kaplan-meier survival analysis and log rank test. to evaluate the association between the clinical variables, cox regression test will be applied. for the cost analysis will be used analysis of variance. the level of significance for all tests will be considered to 5%.


Eligibility criteria:
inclusion criteria: * children aging between 4 and 8 years * children presenting good health conditions * children whose parents or legal guardians accept and sign the consent form * children with at least one occlusal proximal caries lesion in primary molars * only occlusal-proximal surfaces with caries lesions with dentin involvement exclusion criteria: * severe behavioral issues * presence of fistula or abscess near the selected tooth * presence of pulp exposure in the selected tooth * presence of mobility in the selected tooth

Keywords: atraumatic restorative treatment glass ionomer cement primary teeth dental caries.
schizophrenia trial of aripiprazole

Conditions: Schizophrenia

Summary: aripiprazole will show improved effectiveness over the standard of care treatment with one of three atypical antipsychotics (olanzapine, quetiapine and risperidone).


Eligibility criteria:
inclusion criteria: * clinical diagnosis of schizophrenia * schizophrenia symptoms not optimally controlled or antipsychotic medication not well tolerated exclusion criteria: * diagnosis of schizoaffective disorder * patients treatment-resistant to antipsychotics
influencing factors for physical activity in people with head and neck cancer

Conditions: Advanced Head and Neck Squamous Cell Carcinoma

Summary: the goal of this qualitative study is to explore influencing factors for physical activity participation in people affected by an advanced head and neck cancer from the perspective of people affected and their significant others. individual interviews will be conducted with people affected by head and neck cancer and focus group interviews will be held with significant others of people being affected to answer the following research questions: * what capabilities and opportunities for physical activity participation do people with advanced head and neck cancer experience? * what motivates people with advanced head and neck cancer to be physically active? * how do significant others view capabilities, opportunities, and motivation for physical activity participation in people with head and neck cancer? the interviews will be transcribed verbatim and analysed with a structuring content analysis approach.

see attached study protocol

Eligibility criteria:
inclusion criteria for people with head and neck cancer: * minimal age 18 * diagnosis of a primary head and neck squamous cell carcinoma within the last 24 months * oral, pharyngeal, or laryngeal cancer stage iii or iv * completed surgery and/or radio(chemo)therapy in curative intent exclusion criteria for people with head and neck cancer: * not having the physical, mental, and cognitive ability to understand, follow and hold a conversation in (swiss-)german * treatment in palliative intent * recurrence of the head and neck tumour (local or distant) inclusion criteria for significant others of people with head and neck cancer: * minimal age 18 * being a significant other (partner, spouse, close family member or friend) of an individual with a head and neck cancer with the above-mentioned criteria * having the permission of the individual affected by head and neck cancer to talk about their experiences exclusion criteria for significant others of people with head and neck cancer: - not having the physical, mental, and cognitive ability to understand, follow and take part in a group discussion in (swiss-)german

Keywords: qualitative research interviews focus groups physical activity health promotion
non-respiratory comorbidities observed in pulmonary french transplant patients with cystic fibrosis

Conditions: Pulmonary Failure; Cystic Fibrosis

Summary: pulmonary transplantation is the reference treatment for chronic terminal respiratory failure in patients with cystic fibrosis. these are mainly bi-pulmonary transplants (cardiopulmonary transplants are exceptional). the annual number of pulmonary transplants in france for cystic fibrosis is about 90. in 2013, the transplant involves a total of more than 600 patients with cystic fibrosis. the average age at the time of the transplant is 28.5 years (2013 data, french cystic fibrosis register), compared to 58 years for patients transplanted to all pathologies. cystic fibrosis accounts for 25% of adult bi-pulmonary grafts. pediatric transplants are currently very rare. the median survival after pulmonary transplantation in cystic fibrosis is currently 8.5 years (and 10 years when considering patients surviving 3 months, ie excluding early mortality). cystic fibrosis is the pathology associated with better survival after pulmonary transplantation given the young age of patients (28.5 years on average). the non-respiratory comorbidities associated with transplantation, all underlying pathologies combined, and referenced in the registry of the international society for heart and lung transplantation (ishlt) are: hypertension, diabetes, renal insufficiency, dyslipidemia, cancers. their frequency increases with the survival time of transplanted patients. cystic fibrosis is associated with non-respiratory comorbidities, the frequency of which increases with age - diabetes, osteoporosis, renal insufficiency, hepatopathy, neoplastic pathologies - and may become worse after transplantation. the main objective is to estimate the incidence of non-respiratory co-morbidities after lung transplantation in the cohort of patients with cystic fibrosis grafted in the rhône-alpes region.


Eligibility criteria:
inclusion criteria: * patients with clinical diagnosis of cystic fibrosis * patients with pulmonary transplant between 01/01/2004 and 31/12/2014 * patients followed-up in one of the two pulmonary transplantation centers in the rhône-alpes region (lyon, grenoble) exclusion criteria: * patients followed in rhône alpes but transplanted elsewhere in france will not be included. * patient refusing to participate in the study
ovarian function following intraovarian injection of prp

Conditions: Diminished Ovarian Reserve; Diminished Ovarian Reserve Due to Advanced Maternal Age

Summary: consenting women with evidence of poor ovarian reserve will be randomly assigned to treatment with either platelet rich plasma (prp) or platelet poor plasma (ppp).

as women age oocytes are gradually depleted with a consequent progressive loss of ovarian function and fertility. when a woman's follicle cohort falls below a critical level, she enters a transitional time of diminished ovarian reserve known as ovarian aging. recently the use of autologous platelet-rich plasma (a-prp) has been proposed as an additional strategy for improving ovarian function. a-prp is prepared from autologous blood using an fda approved device. the rationale for the use of prp is that it contains growth factors which stimulate cellular anabolism, inflammatory modulators that create an anti-inflammatory effect and fibrinogen which acts as a scaffold for regenerating tissue. the investigators hypothesize that the growth factors present in prp may have a beneficial effect promoting growth and recruitment of antral follicles. the investigators will recruit a prospective cohort of 90 patients with evidence of premature ovarian aging/dor. women invited to participate in this rct will have fsh above 12 and amh below 1.0 ng/ml respectively and will have had fewer than 6 oocytes retrieved in a previous ovulation attempt. consenting participants in this trial will be randomized in a doubly blind fashion to two groups. one will receive platelet rich plasma (prp) and the other will receive platelet poor plasma (ppp). women assigned to ppp will be offerred prp in a future cycle if they so desire.

Eligibility criteria:
inclusion criteria: * fewer than 6 oocytes in response to past ovulation induction * desire to establish a pregnancy using ivf * age 44 years and under. * fsh \> 12 * amh \< 1.0 * no aspirin or motrin for one week before treatment exclusion criteria: * age \> 45 years * marked thrombocytopenia * blood diseases * hypofibrinogenemia * hemodynamic instability * anticoagulant or antiaggregant treatment * oncological diseases (specially, skeletal system and blood) * sepsis * acute and chronic infectious diseases * autoimmune diseases, for example, lupus erythematosus, etc.

Keywords: infertility - ovarian dysfunuction diminished ovarian reserve premature ovarian aging (poa)
intrinsic foot muscle training with and without hip abductor muscle strengthening in pronation distortion syndrome

Conditions: Pronation Deformity of the Foot

Summary: pronation distortion syndrome is one of the most common abnormalities in the lower extremity that causes alterations in the structures of the skeletal parts of the foot. the aim of the study will be to compare the effects of intrinsic foot muscle with and without hip abductor muscle strengthening on pain and functional mobility in patients with pronation distortion syndrome.

a randomized clinical trial will be conducted at nawaz sharif social security hospital, multan road, lahore through convenience sampling technique on 54 patients which will be allocated using simple random sampling through computer generated method into group a and group b. group a will be treated with intrinsic foot muscle training at the frequency of 4 sets with 15 repetitions and group b will be treated with hip abductor muscle strengthening at the frequency of 3 sets with 15 repetitions; session would be conducted thrice a week. outcome measures will be conducted through numeric pain scale and lower extremity functional scale after 6 weeks. data will be analyzed during spss software version 25. after assessing normality of data by kolmogorov-smirnov test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.

Eligibility criteria:
inclusion criteria: * ages 20-30 years * both male and female gender * foot pronation on observation * navicular drop test more than 10 mm (measured in weight bearing and non- weight bearing positions distance between ground and navicular tuberosity and difference calculated) * increased q angle : males: \> 16; females \>18 exclusion criteria: * other deformities such as tarsal coalition and vertical talus * any history of surgery involving both lower extremities * neuromuscular disorder

Keywords: exercise functional mobility muscle strength navicular drop pain pronation
use of a feedback device to limit too shallow compressions associated with the use of an i-gel® device

Conditions: Cardiac Arrest; Cardiopulmonary Arrest; Resuscitation; Emergency Medicine

Summary: airway management in out-of-hospital cardiac arrest is still debated. several options exist: bag-valve-mask ventilation, supraglottic devices and endotracheal intubation. intermediate and advanced airway management strategies could be useful devices to increase chest compression fraction. a previous study shows that early insertion of an i-gel device significantly increases chest compression fraction and enhances respiratory parameters. however, the compressions were found to be shallower in the experimental group using the i-gel device. although, the shallower compressions found in the supraglottic airway device group did not appear to be linked to their provision in an over-the-head position, it is reasonable to assume that the addition of a feedback device to the use of an i-gel® device could fix this issue. the feedback devices seem to be able to provide a benefit, and allow deeper compressions / more often in the depth target. there is a mismatch between perceived and actual cardiopulmonary resuscitation performance supporting the need for such a feedback device's study.


Eligibility criteria:
inclusion criteria: * registered emts and paramedics actively working in any of the participating study trial centers will be eligible for inclusion. exclusion criteria: * members of the study team * emts will be randomly excluded if there are more emts than paramedics.
prevention of invasive fungal infections (ifis) in subjects receiving chemotherapy for acute lymphoblastic leukemia

Conditions: Invasive Fungal Disease

Summary: the study aims to investigate whether prophylaxis with liposomal amphotericin b (ambisome®) can reduce the incidence of invasive fungal infections (ifis) in patients with acute lymphoblastic leukemia (all) who are undergoing their first remission induction.


Eligibility criteria:
inclusion criteria: * newly diagnosed all receiving an all chemotherapy regimen that typically induces at least 10 days of neutropenia defined as an absolute neutrophil count \< 500 cells/mm\^3 or 0.5 × 10\^9 cells/l * subjects with lymphoblastic lymphoma or any malignancy other than all are not eligible for this study. * age ≥ 18 years * able to have all screening tests performed quickly to ensure results can be obtained and evaluated before randomization so that the first dose of randomized study drug for ifi prophylaxis can be administered within 5 days of first remission-induction chemotherapy * preremission induction treatment (ie, pre-phase) with a minimally or nonmyelosuppressive regimen for up to one week is not considered to constitute the beginning of remission induction chemotherapy * ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures exclusion criteria: * known hypersensitivity to amphotericin b or ambisome, the metabolites or formulation excipients, in particular known history of anaphylactic reaction to amphotericin b or ambisome or any of its metabolites or formulation excipients * known hypersensitivity to the excipients of the placebo formulation * current fever (≥ 38°c) unless explained by noninfectious causes * subjects with proven, probable or possible ifi (according to european organization for the research and treatment of cancer/mycoses study group (eortc/msg) criteria) at screening or in subject history * pulmonary infiltrates * concomitant or previous treatment with an antifungal drug within the previous 30 days unless the plasma level is below the limit of detection or at least 5 half-lives of the antifungal has elapsed since the treatment was given * serum creatinine \> 2 × the upper limit of the normal range (uln) * grade 3 liver function test results: alanine aminotransferase or aspartate aminotransferase \> 5 × uln; total bilirubin \> 2.5 x uln * any severe co morbidity other than underlying hematological disease (all), which in the investigator's judgment may interfere with study evaluations or affect the subject's safety * subjects who have taken any investigational drug in the last 30 days prior to screening, with the exception of all chemotherapy investigational products being used as part of the subject's current all treatment protocol * pregnant or nursing females * subjects with a prior history of a malignancy that was treated with a myeloablative chemotherapy regimen are not eligible for this study.

Keywords: ambisome all invasive fungal infection prophylaxis liposomal amphotericin b invasive fungal infection prophylaxis
blood coagulation profile after liver resection.

Conditions: Coagulation Disorder

Summary: liver resection is the treatment of choice in patients with primary or metastatic liver neoplasms, benign liver neoplasms and numerous biliary diseases. in these patients, in the postoperative period,several factors can induce a transient alteration of the synthesis hepatic coagulation factors such as size of the lesion liver, underlying liver disease (e.g. malignancy), pre-existing cirrhosis, duration of both surgery and vascular clamping, and blood loss. so far, some studies have shown that conventional coagulation tests indicate a hypocoagulable state which may lead to excessive transfusions of blood products or an increased risk of thromboembolic events related to delayed initiation of thromboprophylaxis in the postoperative period. in an attempt to optimizing the state of coagulation, recently there is increased interest for viscoelastic coagulation testing (thromboelastography and rotational thromboelastometry). the results of these studies have shown that these patients often have a hypercoagulable and non hypocoagulable profile as evidenced by conventional coagulation tests. the purpose of the study is to evaluate whether the combination of coagulation tests conventional systems and new thromboelastography can increase the quality of surveillance of the coagulation state after liver surgery, in order to optimize the management of postoperative blood coagulation of these patients.


Eligibility criteria:
inclusion criteria: * elective liver resection surgery for liver cancer primary or metastatic * admission to surgical intensive care unit at the end of the surgery. exclusion criteria: * renal disease (creatinine clearance \< 30 ml/min) * pregnancy * benign liver disease * emergency surgery * reintervention